[E-Daily Reporter NA EUN-KYUNG ] U.S.-based gene therapy delivery platform company BreezeBio (formerly GeneEdit) has passed the technology evaluation required for a KOSDAQ listing under the technology exception track and has officially begun the process of listing on the Korean stock market. Following validation of its technological capabilities by global big pharma companies Genentech and Sarepta Therapeutics, the company has now also received recognition of its technological prowess from a specialized domestic evaluation agency, leading to assessments that its prospects for a successful listing have significantly improved.

A Delivery Platform First Validated by Global Big Pharma

According to Breeze Bio on the 6th, the company recently received A and AA ratings from the Korea Technology Finance Corporation and the Korea Research Institute of Bioscience and Biotechnology, respectively. The company plans to apply for a preliminary review for a KOSDAQ listing with the Korea Exchange within six months. Breeze Bio, which recently completed its pre-IPO round, was valued at approximately $200 million (about 270 billion won).

Regarding the company’s strong performance in this technology evaluation, a BreezeBio official stated, “We believe this reflects high recognition of our technology’s distinctiveness and the platform’s level of completion.”

This achievement is particularly significant because, as a foreign corporation, BreezeBio met stricter technology evaluation criteria than domestic companies. Foreign corporations must receive an “A” rating or higher from both technology evaluation agencies to qualify for a technology-based listing, whereas domestic companies can pass the evaluation with an “A” or “BBB” rating or higher. This rating is higher than that of Ingenia Therapeutics, which received “A” and “A” ratings in last year’s technology evaluation.

For a technology-based special listing, clinical-stage pipelines or a track record of major technology transfers are typically considered key competitive advantages. BreezeBio is drawing attention for having passed the technology evaluation by highlighting the competitiveness of its platform technology, even though it does not yet have any clinical-stage candidates. BreezeBio is currently preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a U.S. clinical trial for BRZ-101, a treatment for Type 1 diabetes.

BreezeBio possesses the polymer-based gene delivery platform “NanoGalaxy.” It is characterized by achieving high delivery efficiency while inducing fewer innate immune responses compared to existing non-viral delivery platforms, including lipid nanoparticles (LNPs). It is characterized by organ selectivity, which allows for the selective delivery of drugs to specific organs and tissues, and by minimizing immune responses, thereby increasing the potential for repeated administration.

While most commercially available treatments for autoimmune diseases suppress the entire immune system, NanoGalaxy induces immune tolerance only toward specific antigens that cause the disease. In particular, since NanoGalaxy works by reprogramming the memory of immune cells, BreezeBio expects that new drugs utilizing NanoGalaxy will maintain therapeutic effects for a longer period than existing treatments. Furthermore, the company explains that the platform can incorporate various nucleic acid therapeutics—such as CRISPR gene-editing tools and messenger RNA (mRNA)—and, with its relatively simple manufacturing process, can secure a competitive edge in production.

Building on this technological capability, BreezeBio has successfully established a series of collaborations with global pharmaceutical companies. In 2022, the company signed a joint development agreement for gene-editing therapeutics with Sarepta Therapeutics, a U.S.-based gene therapy specialist, and in 2024, it entered into a joint research and licensing agreement for gene therapies targeting autoimmune diseases with Genentech, a subsidiary of the Swiss pharmaceutical company Roche and a global leader in antibody and gene therapy development. The deal was valued at up to $629 million (approximately 964.6 billion won) at the time.

It appears that Genentech selected BreezeBio’s NanoGalaxy as the delivery vehicle for its autoimmune disease therapy because it simultaneously achieves high delivery efficiency and low immunogenicity. For mRNA therapeutics targeting autoimmune diseases, it is crucial to efficiently deliver the drug to the target cells without excessively stimulating the innate immune system; analysis suggests that BreezeBio’s collaboration resulted from its demonstration of these characteristics in data, including preclinical studies in monkeys.

Furthermore, BreezeBio aims to develop precision medicine-based therapies that induce immune tolerance only toward specific disease-causing antigens, rather than suppressing the entire immune system as conventional autoimmune therapies do. Given the nature of its platform, the therapy can be extended to various autoimmune diseases simply by changing the target antigen, raising expectations for the development of a first-in-class innovative drug.

Technology Validated Globally, Funding Raised on KOSDAQ

BreezeBio’s push for a KOSDAQ listing aligns with the recent trend of Korean-founded biotech companies headquartered overseas choosing the domestic stock market as their listing venue. A strategy of developing technology in the U.S., conducting business with global big pharma, and simultaneously raising growth capital on the domestic stock market is establishing itself as a standard model.

In fact, biotech companies founded in the U.S. by Korean scientists—including Boston-based Ingenia Therapeutics, Cambridge-based Pine Tree Therapeutics, U.S. biotech firm Kaijin, and Breeze Bio—are successively pursuing KOSDAQ listings. These companies all share the common trait of having grown with investment from domestic venture capital (VC) firms from the early stages, even while conducting research and development overseas. Given the high proportion of domestic investors, KOSDAQ is regarded as a practical market where investors can realize returns (exits).

Industry observers predict that, as the slump in the U.S. biotech initial public offering (IPO) market persists, KOSDAQ’s “special technology listing” track will continue to serve as a primary funding channel for early-stage biotech companies, leading to a continued trend of overseas-based biotech firms listing domestically for the foreseeable future. The relatively lower costs associated with listing and maintaining a listing on KOSDAQ compared to NASDAQ are also cited as a key reason for choosing KOSDAQ.

On KOSDAQ, annual fees are calculated based on market capitalization, so the annual burden for most biotech companies is limited to several million won. In contrast, on NASDAQ—though costs vary depending on the listing market and type—annual listing maintenance costs for common stock can reach up to $193,000 (approximately 300 million won).

When accounting and legal advisory fees, as well as investor relations (IR) costs, are added to this, the actual maintenance costs become significantly higher. A biotech industry official stated, “Since companies listed on the Nasdaq must continuously manage their stock price and liquidity even after listing, considerable costs and manpower are invested in IR and promotional activities targeting institutional investors.”

Another advantage cited is the ability to allocate funds raised on the domestic stock market to research and development (R&D) while simultaneously utilizing Korea as a business development (BD) hub for the Asian region.

A Breeze Bio official said, “We plan to pursue a two-track strategy in which our U.S. headquarters will handle the North American and European markets, while we expand our Asian business centered on our R&D center in Korea,” adding, “We intend to develop Korea into a key hub for our Asian business expansion and focus the raised funds on R&D.”